✨ Medicines Distribution Consents




2596 NEW ZEALAND GAZETTE, No. 98 12 JUNE 2008

Schedule

Product:
Tarceva

Active Ingredient:
Erlotinib hydrochloride 109.29mg equivalent to erlotinib 100mg

Dosage Form:
Tablet Film coated

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America

Product:
Tarceva

Active Ingredient:
Erlotinib hydrochloride 163.93mg equivalent to erlotinib 150mg

Dosage Form:
Tablet Film coated

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America

Product:
Tarceva

Active Ingredient:
Erlotinib hydrochloride 27.32mg equivalent to erlotinib 25mg

Dosage Form:
Tablet Film coated

New Zealand Sponsor:
Roche Products (New Zealand) Limited

Manufacturers:
F Hoffmann-La Roche Limited, Basel, Switzerland
Schwarz Pharma Manufacturing Inc, Seymour, Indiana, United States of America

Dated this 3rd day of June 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation
given by the Minister of Health on 6 July 2001).

go4121

Provisional Consent to the Distribution of a Medicine

Pursuant to section 23(1) of the Medicines Act 1981, the Minister of Health hereby provisionally consents to the sale, supply
or use in New Zealand of the medicine set out in the Schedule hereto:

Schedule

Product:
Potassium 10mmol

Active Ingredient:
Potassium chloride 7.385g/L

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Old Toongabbie, New South Wales, Australia

Note: This consent is valid for two years from the date of publication of this notice.

Product:
Potassium 40mmol

Active Ingredient:
Potassium chloride 2.95g/L

Dosage Form:
Solution for infusion

New Zealand Sponsor:
Baxter Healthcare Limited

Manufacturer:
Baxter Healthcare Pty Limited, Old Toongabbie, New South Wales, Australia

Note: This consent is valid for two years from the date of publication of this notice.

Dated this 3rd day of June 2008.

JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate (pursuant to delegation
given by the Minister of Health on 6 July 2001).

go4122

Consent to the Distribution of New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of
the new medicines set out in the Schedule hereto:

Schedule

Product:
Alendrate

Active Ingredient:
Alendronate sodium trihydrate 13.05mg equivalent to 10mg alendronic acid

Dosage Form:
Tablet

New Zealand Sponsor:
Pacific Pharmaceuticals Limited (part of Mylan)

Manufacturer:
McDermott Laboratories, t/a Gerard Laboratories, Dublin, Ireland



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Online Sources for this page:

VUW Te Waharoa PDF NZ Gazette 2008, No 98


Gazette.govt.nz PDF NZ Gazette 2008, No 98





✨ LLM interpretation of page content

πŸ₯ Consent to the Distribution of a Changed Medicine (continued from previous page)

πŸ₯ Health & Social Welfare
3 June 2008
Medicines Act, Changed Medicine, Distribution Consent, Tarceva
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Provisional Consent to the Distribution of a Medicine

πŸ₯ Health & Social Welfare
3 June 2008
Medicines Act, Provisional Consent, Potassium, Baxter Healthcare
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate

πŸ₯ Consent to the Distribution of New Medicines

πŸ₯ Health & Social Welfare
3 June 2008
Medicines Act, New Medicine, Alendrate, Pacific Pharmaceuticals
  • JOHN HAZELDINE, Acting Deputy Director-General, Sector Accountability and Funding Directorate